Review Manager Software 5.3 will be used for meta-analysis. The Cochrane risk of bias tool will be used to assess the risk of bias.
This study will provide a systematic synthesis of current published data to summarize the effect of trimetazidine on incidence of MACE such as stent restenosis, stent thrombosis, new significant coronary stenosis, myocardial infarction, heart failure, and cardiac arrest in CAD patients undergoing PCI.
This meta-analysis will provide evidence as to whether trimetazidine can reduce incidence of MACE in CAD patients undergoing PCI.
INPLASY202090083.
INPLASY202090083.Chinese medicine Sangbaipi decoction is extensively applied to the therapy of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in China. However, owing to the low quality, small sample size, and methodological heterogeneity of these studies, this conclusion is not convincing. Consequently, it is necessary to systematically evaluate the clinical efficacy and safety of Sangbaipi Decoction in the treatment of AECOPD patients, and provide high-quality evidence for its clinical application.
We will follow the preferred reporting items for systematic review and meta-analysis (PRISMA) for reporting the results of the review in this study. We will utilize the Review Manage software V5.3.0 (The Nordic Cochrane Center, The Cochrane Collaboration, 2014, Copenhagen, Denmark) to assess the risk of bias and visualize the results. We will use Stata software (version 15.0, StataCorp, College Station, TX) to perform the meta-analysis.
This study is a systematic review and meta-analysis protocol of Sangbaipi decoction on AECOPD, participants were not recruited and data were not collected from participants, so ethical ratification is not required.
This study will provide high-quality synthesis of the effectiveness and safety of Sangbaipi decoction for AECOPD. Upon completion, the results will be submitted to a peer-reviewed journal.
The efficacy and safety assessment of Sangbaipi decoction for AECOPD will be supported by this protocol.
PROSPERO CRD 42019138405.
PROSPERO CRD 42019138405.The Pharmaceutical industry sponsorship, research outcome and quality has been already evaluated for clinical trials in order to analyze if this kind of sponsorship affects the results of clinical trials. In this sense, this study has the aim to investigate whether placebo use allows positive outcomes regarding efficacy and safety compared to synthetic medicines.
We designed and registered a study protocol for a systematic review for methodology data. We will only randomized clinical trials that use placebo as comparator. The main outcome will be the evaluation of placebo use regarding the tendency for positive results (efficacy and security) when comparing to synthetic medicines. PubMed, Cochrane, LILACS (BVS), Web of Science, Scopus, and Excerpta Medica dataBASE (EMBASE) databases will be searched. Gray literature will be identified through the databases Proquest (Dissertation and Theses), OpenGrey and Google Scholar. Two review authors will independently assess trial quality and will extract data in accordance with standard Cochrane methodology. If necessary, we will also contact authors for additional information. The Cochrane Collaboration's risk of bias tool will be used. If feasible, it means homogenous data, we will conduct random effects meta-analysis. Subgroup analyses will be conducted for different justifications for placebo use and for studies sponsored/not sponsored by the pharmaceutical industry.
Our present findings will indicate the effects of placebo use as comparator regarding efficacy and safety of the oral synthetic medicines.
This systematic review will identify, summarize, and analyze if there is a trend for positive efficacy and safety results for synthetic medicines in clinical trials when compared with placebo and if the justification for placebo use is considered ethically acceptable.
PROSPERO CRD42018110829.
PROSPERO CRD42018110829.Malignant cutaneous epithelial tumors comprise various skin malignancies originating from the cutaneous epithelium, including cutaneous squamous cell carcinoma, basal cell carcinoma, and malignant cutaneous adnexal tumors. Treatment options are limited, as the rarity of these tumors, especially among Asians, renders well-controlled clinical trials extremely challenging to conduct. Thus, we designed a clinical trial to evaluate the efficacy and safety of the anti-programmed cell death-1 (PD-1) monoclonal antibody nivolumab in patients with metastatic cutaneous squamous cell carcinomas and other rare metastatic cutaneous epithelial tumors.
This is an open-label, single-arm, multicenter, phase 2 clinical trial involving patients with metastatic malignant cutaneous epithelial tumors. Nivolumab (480?mg) will be administered intravenously every 4 weeks for a maximum of 26 doses. The primary outcome of the study will be the response rate based on response evaluation criteria in solid tumors, version 1.1. Assuming a null hypothesis of a response rate ?5% and an alternative hypothesis of a 25% response rate, a minimum of 26 patients are required to achieve a 5% two-sided type I error and 80% power based on the exact binomial distribution. Finally, a target cohort size of 30 patients was determined as some patient dropout will be expected.
This is the first phase 2 clinical trial evaluating the efficacy and safety of the PD-1 inhibitor nivolumab in Asian patients with metastatic malignant cutaneous epithelial tumors. The findings of the study will contribute to the development of novel treatment approaches for patients with rare cutaneous malignancies, which remains an unmet clinical need.
Registry number jRCT 2031190048.
Registry number jRCT 2031190048.The aim of this study was to investigate the clinical characteristics of central nervous system (CNS) aspergillosis in immunocompetent patients.This study enrolled six immunocompetent patients diagnosed with CNS aspergillosis. Additionally, we reviewed the clinical profiles for 28 cases reported in the literature. The age, gender, etiology of Aspergillus infection, clinical manifestations, location of the lesion, treatment, and prognosis were analyzed.There were 19 men (average age, 54.6?±?14.3 years) and 15 women (average age, 47.0?±?19.4 years). https://www.selleckchem.com/products/sivelestat-sodium.html The clinical manifestations included headache (55.9%; n?=?19), visual impairment (32.4%; n?=?11), diplopia (32.4%; n?=?11), hemiplegia (20.6%; n?=?7), fever (17.6%; n?=?6), and epilepsy (8.8%; n?=?3). According to the radiological features, CNS aspergillosis lesions were divided into two subtypes parenchymal lesions in the cerebral lobes (n?=?11), and meningeal lesions in the meninges (n?=?23). The patients with meningeal lesions are easy to be complicated with more serious cerebrovascular diseases, such as subarachnoid hemorrhage and massive infarction.